Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Retrospective Registry for the Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05773170
• Other study ID #: CC01897112
• Status: Completed
• Start date: November 11, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this retrospective registry is to evaluate the efficacy and safety of Refralon®, concentrate for solution for intravenous injection, as chemical cardioversion in patients with paroxysmal and persistent atrial fibrillation and flutter in routine clinical practice. The main questions it aims to answer are:

• What is the incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal atrial fibrillation (AF)/atrial flutter (AFL) after the first dose of Refralon®?

• What is the incidence of sinus rhythm restoration within 24 hours in patients with persistent AF/AFL after the first dose of Refralon®?

Description:

The registry is a retrospective multicenter observational study in patients with paroxysmal and persistent forms of AF and AFL who underwent chemical cardioversion with Refralon® in a hospital setting.

After the compliance with the inclusion criteria and the absence of exclusion criteria based on medical documentation, the patient data will be collected from medical documentation available for the analysis into a unified electronic case report form (eCRF).

Alongside the study therapy, all the patients must receive an adequate anticoagulant therapy in accordance with the current clinical guidelines of the Ministry of Health of the Russian Federation. After chemical cardioversion, patients were followed up and examined as a part of routine clinical practice. The examination data will be used for this study analysis. No additional therapeutic or diagnostic procedures are provided by the analysis protocol.

Study patient follow-up period was 24 hours from the Refralon® first dose administration.

The patients' data collection is planned for 8 months. It is planned to enroll 1500 patients with persistent and paroxysmal AF and AFL, meeting the inclusion/exclusion criteria. If necessary, it is possible to extend the registry data collection period to include the planned number of patients.

Approximately in 3 and 6 months from the registry initiation (but not earlier than after the inclusion of 150 patients into the registry), an interim collected data analysis can be performed in order to preliminary assess the Refralon® efficacy and safety data in this study, as well as to identify the potential data entry errors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1147
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis: paroxysmal or persistent atrial fibrillation or flutter;

• A chemical cardioversion procedure performed with Refralon® in a hospital setting.

Exclusion Criteria:

• Congenital or acquired QT interval prolongation in the electrocardiogram (ECG) in 12 standard leads for more than 440 ms at the time of cardioversion;

• Bradysystolic atrial fibrillation or flutter (mean heart rate < 50 bpm or pauses > 3 sec, registered on the ECG or identified by the results of 24-hour Holter ECG monitoring, except for the cases of its correction by a cardiac pacemaker at the time of cardioversion;

• Sick sinus syndrome (sinus bradycardia, sinoatrial blockade), previously registered as associated with sinus rhythm, except for the cases of its correction with a cardiac pacemaker at the time of cardioversion;

• Degree II - III atrioventricular blockade, two- and three-beam blockade with no cardiac pacemaker at the time of cardioversion;

• Acute myocardial infarction period at the time of cardioversion;

• Acute period after coronary artery bypass grafting (CABG) or other cardiac surgery (at least 7 days after CABG at the time of cardioversion);

• Decompensated or severe chronic heart failure (III-IV functional class according to New York Heart Association (NYHA) classification) at the time of cardioversion;

• Uncontrolled bronchial asthma, severe respiratory failure at the time of cardioversion;

• Pregnancy and breastfeeding at the time of cardioversion;

• Administration of Class IA antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide, procainamide) at the time of cardioversion;

• Class III antiarrhythmic drugs administration at the time of cardioversion;

• Cardiac glycosides administration at the time of cardioversion;

• Administration of QT-prolonging drugs at the time of cardioversion;

• Heart rate < 50 bpm, pauses > 3 seconds on the ECG or Holter ECG monitoring (HM-ECG) during wakefulness at the time of cardioversion;

• Hyperthyroidism or decompensated hypothyroidism (thyroid stimulating hormone (TSH) < lower limit of normal or > 2 upper limits of normal) at the time of cardioversion;

• Uncorrectable electrolyte disorders (potassium level less than 3.5 mmol/L) at the time of cardioversion;

• Identified contraindications to the sinus rhythm restoration at the time of cardioversion;

• Blood clots in the heart cavities or spontaneous grade III-IV echo contrast at the time of cardioversion according to transesophageal echocardiography;

• The need for electrical cardioversion due to the patient's hemodynamic instability at the time of cardioversion.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Drug:
• Refralon
1 mg/ml concentrate for solution for intravenous injection. (Prior to the administration, 2 mL of Refralon® must be diluted to 20 mL in 0.9 % sodium chloride).

Locations

Country	Name	City	State
Russian Federation	The Regional State Budgetary Healthcare Institution "St. Joseph Belgorod Regional Clinical Hospital"	Belgorod
Russian Federation	State budgetary Healthcare Institution "Cardiological Dispensary"	Ivanovo
Russian Federation	"First Clinical Medical Center" LLC	Kovrov	Vladimir Region
Russian Federation	Federal State Budget Institution "A.N. Bakulev National Medical Research Center of Cardiovascular Surgery" of the Ministry of Health of the Russian Federation	Moscow
Russian Federation	Federal State Budgetary Institution "Clinical hospital ? 1" administrative Department of the President of the Russian Federation	Moscow
Russian Federation	Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Health?are of the Russian Federation	Moscow
Russian Federation	State Budgetary Healthcare Institution "City Clinical Hospital named after I.V. Davydovsky of Moscow Healthcare Department"	Moscow
Russian Federation	State Autonomous Healthcare Institution of the Kemerovo Region "Novokuznetsk City Clinical Hospital ? 1"	Novokuznetsk	Kemerovo Region
Russian Federation	State Budgetary Healthcare Institution of the Novosibirsk region "City Clinical Hospital ? 2"	Novosibirsk
Russian Federation	State Budgetary Healthcare Institution of the Novosibirsk Region "Novosibirsk Regional Clinical Cardiology Dispensary"	Novosibirsk
Russian Federation	Clinical Health Unit No. 9	Omsk
Russian Federation	State Budgetary Healthcare Institution of the Perm Region "Clinical Cardiological Dispensary	Perm
Russian Federation	State Budgetary Institution of the Ryazan region "Regional Clinical Cardiology Dispensary"	Ryazan
Russian Federation	Samara City Clinical Hospital ? 1 named after N.I. Pirogov	Samara
Russian Federation	The State Budgetary Healthcare Institution of the Samara Region "Samara Regional Clinical Cardiology Dispensary named after V.P. Polyakov"	Samara
Russian Federation	State Health Care Institution "Regional Cardiology Clinic"	Saratov
Russian Federation	Federal State Budgetary Institution "National Medical Research Center (NMIC) named after V. A. Almazov" Ministry of Health Russia	St. Petersburg
Russian Federation	St. Petersburg State Budgetary Healthcare Institution "Hospital for War Veterans"	St. Petersburg
Russian Federation	The Saint Petersburg State Health Care Establishment the City Hospital ? 40 of the Resort District	St. Petersburg
Russian Federation	Tambov Regional State Budgetary Healthcare Institution "S.S. Bryukhonenko City Hospital of Michurinsk"	Tambov
Russian Federation	Cardiology Research Institute, Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"	Tomsk
Russian Federation	State health institution City Hospital ? 13 Tula (Tula regional cardiological dispensary)	Tula
Russian Federation	The State Budgetary Healthcare Institution of the Tver region "Regional Clinical Hospital"	Tver
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry for Healthcare of the Russian Federation	Ufa	Bashkortostan Republic
Russian Federation	State Budgetary Healthcare Institution of Republic of Bashkortostan "City Hospital Clinical Hospital ? 21"	Ufa	Bashkortostan Republic
Russian Federation	The State Budgetary Healthcare Institution of the Vladimir Region "State Hospital ? 4"	Vladimir
Russian Federation	The State Budgetary Healthcare Institution "Volgograd Regional Clinical Cardiology Center"	Volgograd
Russian Federation	Budget Healthcare Institution of the Vologda Region "Vologda Regional Clinical Hospital"	Vologda
Russian Federation	The State Healthcare Institution "Voronezh Regional Hospital ? 1"	Voronezh
Russian Federation	The State Budgetary Health Care Institution of the Yaroslavl Region "Regional Clinical Hospital"	Yaroslavl
Russian Federation	State Budgetary Healthcare Institution of Sverdlovsk Region "Scientific-practical center of specialized typed of medical care "URAL INSTITUTE OF CARDIOLOGY"	Yekaterinburg	Sverdlovsk Region
Russian Federation	State Budgetary Healthcare Institution "Sakhalin Regional Clinical Hospital"	Yuzhno-Sakhalinsk
Russian Federation	State Budgetary Healthcare Institution of the Sakhalin region "Yuzhno-Sakhalinsk City Hospital named after F.S. Ankudinov"	Yuzhno-Sakhalinsk

Sponsors (2)

Lead Sponsor	Collaborator
R-Pharm	FSBI "National Medical Research Center of Cardiology named after academician E.I.Chazov" of the Ministry of Health of the Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sinus rhythm restoration	Incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal AF/AFL after the first dose of Refralon®	up to 6 hours
Primary	Incidence of sinus rhythm restoration	Incidence of sinus rhythm restoration within 24 hours in patients with persistent AF/AFL after the first dose of Refralon®	up to 24 hours
Secondary	Time from the Refralon® administration start to the sinus rhythm restoration		from Refralon® administration to the sinus rhythm restoration, up to 24 hours
Secondary	Incidence of sinus rhythm maintenance	Incidence of sinus rhythm maintenance in patients 24 hours after the first Refralon® dose	up to 24 hours
Secondary	Incidence of AF/AFL sustained recurrences	Incidence of AF/AFL sustained (for more than 30 seconds) recurrences within 24 hours after the successful cardioversion with Refralon®	up to 24 hours